结核抗体检测试剂盒用血清标准品的制备及应用

目的 结核抗体检测试剂盒质量控制用血清标准品的制备及应用。方法 采集结核病患者和健康人血清，用ELISA法进行检测，制备血清标准品：包括10份检测结果为阳性的结核病患者血清、10份检测结果为阴性的健康人血清、1份检测结果为强阳性的结核病患者血清用健康人血清进行倍比稀释而成的5个稀释浓度；并对血清标准品进行稳定性试验；同时用本套血清标准品对不同厂家生产的结核抗体检测试剂盒以及同一厂家生产的不同批号的结核抗体检测试剂盒进行测定。结果 本血清标准品具有良好的稳定性;不同厂家生产的结核抗体检测试剂盒质量不均一，同一厂家生产的试剂盒质量也不均一。结论 本血清标准品可以用于结核抗体检测试剂盒的质量控制；各生产厂家要严格按照生产工艺的SOP进行生产，把好质量关。

Application and preparation of the serum standard panel for the control of tuberculosis antibody test kits

Objective Application and preparation of the serum standard panel for the quality control of tuberculosis antibody test kits.Methods Serum samples were collected from tuberculosis and healthy volunteers.The antibody determinations were performed on the serum specimens by ELISA.Then the serum standard panel was prepared,consisting of 10 member known positive sera from tuberculosis volunteers,10 member known negative sera from healthy volunteers and 5 member two-fold serum dilutions from 1:2 to 1:32 of the same known high positive serum.And the stability of the serum standard panel was studied.And the tuberculosis antibody test kits from the diffirent manufacturers and the diffirent kit lot numbers of the same manufacturer were evaluated with the serum standard panel.Results The serum standard panel showed good stability.The qualities of the tuberculosis antibody test kits from the different manufacturers were not equal as well as those of the different lot numbers of the same manufacturer were not equal.Conclusion The serum standard panel can be used for the quality control of tuberculosis antibody test kits.The test kits must be made according to the standard operation procedure.The manufactures must provide the best quality products.